Life Sciences, deals, sirtris Ryan McBride wrote: Sirtris is now part of pharmaceutical behemoth GlaxoSmithKline (NYSE:GSK), but the British giant has allowed its acquisition a unique dose of autonomy since it bought the small, Cambridge, MA-based biotech in June for $720 million. For those who still haven’t heard, Sirtris is known around the world for the dazzling potential of its drugs to lengthen healthy human lifespan. Christoph Westphal, CEO of Sirtris, says his company will have some exciting news to share next month about the first human tests of its next-generation drugs—which will likely make it even better-known. Yet, when I caught up with him last week, the news about its trials was just one of several insights Westphal shared about what’s been brewing at Sirtris this summer. Xconomy: What are the perks of Big Pharma ownership? Christoph Westphal: There’s actually a lot of perks. I think the most important one is we think it is much more likely we’re going to get a drug to market than it was before. And there are several reasons for that. We have a budget that we’ve just been given for the next three years, which is 30 to 50 percent greater than we could have afforded as an independent company. Secondly, we have an opportunity to leverage global GSK, so there’s a lot of skill sets and abilities and machines and scale-up capabilities. It’s literally dozens and dozens of things that we never could have done on our own that we can now do as part of GSK. X: What makes Sirtris unique from other biotechs acquired by Big Pharma? CW: Both GSK and we were interested in keeping Sirtris independent and autonomous, which is why we’ve retained our name, we’ve retained our management structure [no more board of directors anymore, of course], we had a strong incentive to retain our employees, which we’ve done, and really almost all decisions are made almost exactly the same way they were before. That may be a little bit different than some acquisitions, where quickly the company was no longer autonomous. Literally, there’s no one here from GSK, five months after we announced the acquisition. And they’ve been very hands-off in all of our decisions. I think they are very smart and careful and thoughtful. So we pitched them on what our three-year plan is, but they are basically funding us like venture guys would fund us or public market folks would fund us, saying, ‘Day-to-day decisions are totally up to you, but we do expect in the next several years you to generate significant value,’ which I think is fair. X: How long do you plan to stay with Sirtris? …Next Page » Comments | Permalink | Share |  E-mail Less

deals, acquisitions, Drug Development Wade Roush wrote: Phase Forward (NASDAQ: PFWD), a Waltham, MA-based company whose software is used by large pharmaceutical companies and research institutions to manage the huge amounts of data generated by clinical drug trials, said today that it has acquired Clarix of Radnor, PA, for $40 million in cash. Clarix makes hybrid phone- and Web-based interactive voice response systems that help the organizers of drug trials to manage drug supplies at trial sites. Permalink | Share |  E-mail Less

Curis, cancer, Life Sciences Ryan McBride wrote: Drug developer Curis (NASDAQ:CRIS), of Cambridge, MA, reported today that it has begun a Phase 1 clinical trial of an anti-cancer small molecule, dubbed CUDC-101. The experimental drug is designed to inhibit tumor cell growth and survival, and 18 to 40 patients are expected to enroll in the clinical trial. Permalink | Share |  E-mail Less

Biotech, Drugs, clinical trials Luke Timmerman wrote: Dyax looks like it may have just transformed into a commercial drug company today. Shares in the Cambridge, MA-based company (NASDAQ: DYAX) shot up 15 percent today after it said its lead drug in development, DX-88, helped patients in a late-stage clinical trial with a rare, life-threatening disease called hereditary angioedema. Investors drove Dyax shares up 67 cents to $5 at the close of markets. The company said its experimental drug, given as an injection, worked in a trial of 96 patients with hereditary angioedema. It’s a genetic condition that causes rapid pain and swelling, particularly of the face and lungs. The trial, called Edema4, found that 94 percent of patients had a successful response to the drug at four hours following an attack, compared with 58 percent who did that well on a placebo. About 44 percent of patients on the drug reported that they felt “a lot better or resolved” for a full 24 hours after treatment, compared with 21 percent of patients in the placebo group. Dyax, founded in 1995, is best known for a phage display technology that its licenses to other drugmakers as a discovery tool. It has no marketed products of its own, and has run up a $335 million deficit in its history, according to its most recent quarterly report with the Securities and Exchange Commission. Based on the results of the DX-88 trial, which match up with another pivotal study, the company plans to submit an application to the FDA to market the product shortly after the fourth quarter begins on Oct. 1. An estimated 10,000 patients in the U.S. have hereditary angioedema, although without yet setting a price for the drug, Dyax declined to specify how big it considers the potential market to be. “This is good news for Dyax and for patients too,” said Mark Monane, an analyst with Needham & Co. on a conference call this morning with the company. Dyax chief business officer Gustav Christensen said the company plans to market the product without a partner in the U.S.. It could face competition from Firazyr, a product approved for sale in Europe. That drug was developed by German drugmaker Jerini AG, which London-based Shire is attempting to take over. Another drug for hereditary angioedema that’s close to reaching the U.S. market is Cinryze, which is produced by Lev Pharmaceuticals of New York. Exton, PA-based Viropharma (NASDAQ: VPHM) said last month it had agreed to acquire Lev and obtain the rights to that product. Dyax sounds confident in how its contender stacks up. When pressed by Monane to characterize the clinical trial results, CEO Henry Blair said, “I’d classify them as excellent. We’re very pleased with the result.” It may not be long before doctors and patients weigh in with their own verdict on how much the drug is really worth. Comments | Permalink | Share |  E-mail Less

Biotech, cancer, clinical trials Gregory T. Huang wrote: As Luke reported a couple weeks ago, Seattle-based Dendreon is in the midst of a crucial clinical trial of its cancer drug, Provenge, against prostate cancer. Interim results from 500 patients in the trial, called Impact, are expected in October. In a conference call this afternoon, Dendreon announced its second-quarter 2008 financial stats, as well as giving a brief update on two other, smaller clinical trials of Provenge. “We’re continuing to make progress on multiple fronts, including our pipeline,” said CEO Mitchell Gold. “Our foremost priority remains advancing Provenge through the approval process.” Indeed, if the drug goes on to gain FDA approval and takes off, the commercialization plan calls for building a sales team in the U.S. and an outside partnership to distribute the drug abroad, said Gold. Dendreon has just begun enrolling patients in its NeoACT trial, which will involve 40 patients at the University of California, San Francisco, with localized prostate cancer who are scheduled to undergo a prostatectomy. The clinical trial “provides us with an opportunity to look directly at the organ, the prostate, and its immunotherapy response,” said David Urdal, Dendreon’s chief scientific officer. Another clinical trial of Provenge, called ProACT, is expected to begin later this month. It is a multi-center trial involving about 120 patients with metastatic prostate cancer. The goal, said Dendreon, is to gain new scientific insight into Provenge, and gauge its impact on patients. In a statement, Dendreon (NASDAQ: DNDN) reported a Q2 loss of $16.5 million (18 cents per share), and its quarterly revenue dropped to $26,000 from $523,000 in Q2 of 2007. The company said it holds $127.3 million in cash, cash equivalents, and investments, including $46 million raised in a stock offering in April. Comments | Permalink | Share |  E-mail UNDERWRITERS AND PARTNERS Less

Biotech, cancer, clinical trials Luke Timmerman wrote: Ariad Pharmaceuticals (NASDAQ: ARIA), the Cambridge, MA-based developer of cancer drugs, said today it has started a mid-stage clinical trial of a breast cancer treatment designed to help patients who resist Genentech’s Herceptin. The drug, an oral pill called deforolimus, is designed to block the mTOR protein, which acts like a “master switch” for cancer cells. Ariad will now receive a $15 million milestone payment from its partner, drug giant Merck (NYSE: MRK) for starting the study. The trial, of 33 patients, should wrap up in the second half of 2009. Permalink | Share |  E-mail Less

Biotech, Alzheimer's, clinical trials Luke Timmerman wrote: Epix Pharmaceuticals is having a wild year with its Alzheimer’s drug development program. Shares in the Lexington, MA-based company (NASDAQ: EPIX) shot up 35 percent in one day in December after it said its drug produced one of the best improvements ever in memory and thinking skills for Alzheimer’s patients in a clinical trial. One month later, the gains were wiped out when a major goof-up was revealed. Epix said its contract research organization made mistakes crunching the numbers, so the improvement in patients’ cognition score was 3.6 points on a standard scale, not the 5.7 point gain previously reported. “Obviously, we are not using those folks anymore,” says Epix CEO Michael Kauffman. Now Epix is trying to set the record straight for good. The company plans to present full results from the mid-stage trial at the International Conference on Alzheimer’s Disease in Chicago that runs July 26-31. About 5,000 researchers will gather there to learn about the latest research against this incurable disease, which robs people of their memory and thinking skills and affects more than 5 million Americans, according to the Alzheimer’s Association. The key finding for Epix is still the same as what the company reported January—that 10 patients who took a daily, 150 milligram dose of the drug by itself for two weeks had a 3.6 point improvement in their ADAS-cog score, a standard measurement of memory and thinking skills, compared with a 0.9 point worsening for 10 patients on placebo. Some more data is available from a computer test that patients took, which verifies the benefit, and suggests Epix’s drug may also work in tandem with Aricept, the Alzheimer’s treatment from New York-based Pfizer (NYSE: PFE) and Tokyo-based Eisai, Kauffman says. No serious side effects of Epix’s drug were seen in the study. One of the strengths of the study is that it showed a benefit so quickly, although critics will say Epix still needs to demonstrate that the drug has a sustained effect over six months, Kauffman says. The company doesn’t have that proof yet, Kauffman says, but it plans to present some interesting results from a couple of trial volunteers who asked to continue taking the drug after the two-week study ended. In response to the patients’ request for more drug, the company made a special petition to the FDA for a six-month extension of the study for those two individuals. The request was granted, Kauffman says, because Alzheimer’s patients have so few treatment options. The two patients in the extended trial had periods where they went off treatment, and showed “profound” improvement when they went back on, Kauffman says. “You don’t have to be a physician to see progress when a patient can suddenly play cards when they couldn’t before,” Kauffman says. Epix’s drug, called PRX-03140, is designed to work unlike any marketed Alzheimer’s drug, by stimulating production of a neurotransmitter in the brain called acetylcholine. In the study, it didn’t produce the key side effect of Aricept, nausea. The market is obviously huge for Alzheimer’s—Aricept, the most-prescribed Alzheimer’s medicine worldwide, generated $2.16 billion in worldwide sales in the fiscal year ended in March 2007. That’s for a drug that doesn’t really improve cognition, but can slow down the patients’ decline. Epix and partner GlaxoSmithKline (NYSE: GSK) are recruiting patients into larger trials that could go a long way toward demonstrating if the experimental drug really has legs. One trial of 420 patients will compare two different doses of the Epix drug in combination with Aricept against placebo, measuring the ADAS-cog score after six months. A second study of 240 patients will compare the Epix drug to Aricept and to placebo. That trial will run for three months, with another three-month extension. The latter study should produce its first results in mid-2009, Kauffman says, while the larger trial in combination with Aricept will take longer, delivering findings in the first half of 2010, he says. By that time, more data will be available on competitors like drug giant Wyeth (NYSE: WYE) and Elan’s bapineuzumab, and Medivation’s (NASDAQ: MDVN) Dimebon. Some of the buzz at the meeting will also be about the failure last month of a clinical trial of Flurizan, an experimental drug from Salt Lake City-based Myriad Genetics. There may be something to learn from it, Kauffman says. The failure of Flurizan has gotten some researchers casting around again for promising new leads. It certainly hasn’t hurt a company like Epix, with a new method of treatment, at an earlier stage of development. “People in the field are starting to feel like we’re asking the right questions,” Kauffman says. “We’re getting some more calls and more interest about our program.” Comments | Permalink | Share |  E-mail Less

Biotech, cancer, clinical trials Luke Timmerman wrote: Dendreon, the Seattle-based maker of immune-boosting therapies for cancer, said today it has started a mid-stage clinical trial of Provenge for patients with localized prostate cancer who are about to have their prostates surgically removed. The trial, called NeoACT, will enroll about 40 patients at the University of California San Francisco. That study will be getting underway as the company (NASDAQ: DNDN) awaits big news in the coming months from a trial of 500 men that will examine whether Provenge can extend lives when used against more advanced forms of prostate cancer. Comments | Permalink | Share |  E-mail Less

Biotech, cancer, clinical trials Luke Timmerman wrote: Calistoga Pharmaceuticals, a Seattle biotech startup backed by Frazier Healthcare Ventures, said today it has started its first test in humans of its lead drug candidate for patients with blood cancers. The treatment, a small-molecule compound called CAL-101, is designed to block the PI3 kinase, which controls cell growth and survival signals. The trial will enroll 60 patients, measuring safety at a range of doses, according to a description at clinicaltrials.gov. Comments | Permalink | Share |  E-mail UNDERWRITERS AND PARTNERS Less

medical devices, acquisitions, Stroke Luke Timmerman wrote: Northstar Neuroscience is in one tight spot. The Seattle-based medical device company’s lead product candidate for stroke patients failed in clinical trials on Jan. 22, and 83 percent of its stock value (NASDAQ: NSTR) evaporated in a heartbeat. Then yesterday, San Diego-based Tang Capital Partners, its largest shareholder, made an unsolicited bid to buy the whole company at a bargain price that says Northstar is worth less than the technology it has in the bank. Kevin Tang, the investment firm’s managing member, announced his offer of $2.25 a share in cash, which pegs Northstar’s value at about $58.7 million, a 50 percent premium over the company’s closing stock price before his bid was released. Sounds good for shareholders, right? Actually, Northstar had $77.9 million in cash and investments in the bank when it last reported financials at the end of March, meaning that Tang could theoretically buy the company, fire everybody, liquidate assets immediately, and come out ahead. Northstar CEO John Bowers didn’t do any interviews yesterday, although the company did issue a statement that said it “will review and consider the offer consistent with its fiduciary duties.” Last month, the company tried to shift investors’ attention to potential use of its implanted brain-stimulation technology for patients with depression, yet results to date are still in the early stages and the stock didn’t budge. Yesterday, the company also hired Boston-based investment bank Leerink Swann to evaluate the proverbial “strategic alternatives.” The alternatives obviously don’t look so hot. Tang said he wants a positive response from the company by July 9, and for Northstar to agree to hand over the company by July 23. If the Northstar board turns Tang down, he could make a direct appeal to shareholders to take over the company through what is known as a “tender offer.” Shareholders don’t seem to think Tang’s bid is a sure thing. The stock jumped 23 percent to close at $1.84, but it’s still a long way from the $2.25 offer. “It’s not exactly going out on a limb to say investor interest in early stage biotechs is at fairly low levels,” said Paul Latta, an analyst with McAdams Wright Ragen in Seattle. Despite news of an unsolicited takeover bid of a local company, the phones didn’t exactly ring at his firm. “I know two guys who own the stock, and they’re both on vacation.” It’s a sad state of affairs for a company that went public in 2006 at $15 a share. Early clinical trials showed that Northstar’s technology, dubbed a pacemaker for the brain, could send electrical impulses through the brain’s outer coating that were able to restore some patients’ arm and hand movement after a stroke. Natick, MA-based Boston Scientific thought enough of it to invest $20 million in the company in 2004. The fact that it didn’t pan out in a pivotal clinical trial, called Everest, was not just bad news for investors, but also for 250,000 stroke survivors in the U.S. who live with long-term hand/movement disabilities. Comments | Permalink | Share |  E-mail Less

clinical trials, italy, Drug Development Erik Mellgren wrote: The newly-formed Clinical Research Consortium of Massachusetts has signed an agreement with the government of the Lombardy region in northern Italy to help make the area more attractive to drug companies seeking to do clinical research. Today, Italy only has a small sliver, about two per cent, of the multibillion-dollar European market for clinical trials. But according to Bonnie Brescia, founding principal of Newton, MA-based patient recruiting service BBK Worldwide, one of the consortium’s members, the group believes that Lombardy—already home to about half of Italy’s biotech companies—can become a major player in European clinical research. The consortium also includes Tufts Medical Center’s Institute for Clinical Research & Health Policy Studies, Waltham, MA-based clinical trials management company Phase Forward (NASDAQ: PFWD), and IT consulting firm Court Square Group. The Lombardy program could benefit the Massachusetts life sciences industry by making it easier and faster for New England drug companies to do certain clinical trials, says Brescia. “In some cases it is very hard to do trials in the United States, as our population tend to move around so much. It will be very helpful to have access to a region like Lombardy with a very stable population and long clinical records.” Adds Brescia, “There is a lot of work to be done, but the local government is prepared to go forward with this big program and really invest in making the region a center of excellence not only in Italy but in Europe. They are prepared to tackle it on many levels.” The consortium is also in talks with both government and private organizations about similar projects in other countries in Europe and Latin America. Comments (1) | Permalink | Share |  E-mail Less

Another fast paced, action packed, fact filled hour(1/2 hour without commercial break) comes your way from the medical capital of the world with “The Corner Pharmacist”. Topics discussed this session are the availability of new generic equivalent prescription drugs for Coreg and Famvir…a blood pressure medicine and an antiviral. A new, less expensive generic version of the popular over the counter(OTC) cream medicine for athlete’s foot, jock itch, ringworm is now available at most fine pharmacies in the United States…Lamisil cream is now generic! Few teens are getting their meningitis shot before heading to college if they missed it when they were in their early teens. Flu shots will begin before next month’s show…the first week of October! Visit the website for dates/times and fees, our pharmacy practice will offer the most complete and comprehensive clinics by also offering pneumonia and tetanus shots to the public also during our 12 dates in a community pharmacy setting. AND there are bills moving through both chambers of the United States Congress that would force PBM’s(Prescription Benefit Managers such as Medco, Caremark, Paid) to pay Pharmacists within 14 days of receipt of a patient’s billing for a medication provided under any Medciare Part D plan. Those bills are HR 1474 and SF 1954…call your member of Congress and urge them to cosponsor these bills and force a vote. PBM’s get their payments from the government at the beginning of each month but a recent University of Texas study showed on average the community Pharmacist was getting paid for claims submitted electronically(called on-line/real-time) like a credit card aren’t being paid for close to 45 days!!! This causes extreme difficulties for the Pharmacist who has to pay his wholesaler that supplies the medications every 14 days. Close to 1,200 pharmacies have had to close their doors in the United States due to this discrepancy in payment timing from the PBM’s. It’s time Congress reign in the free hand of the PBM’s with this law!!! Several excellent phone calls are also featured on a variety of health topics, listen for the answers!!! “LET US NEVER FORGET WHAT HAPPENED TO US ON SEPTEMBER 11, 2001!” The show features many patriotic songs as bumper music today. Enjoy and send some email to “Ask the Pharmacist” via the website. Less

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Merry TWISMAS!!!, TWIS Digg Contest: Win a Free TWIS Tshirt and Science Music CD, Bacteria Around Us, Starlight Stardust, Frigid Faithful, Justin Raves About Circumcision, & Interview w/ Dr. David Weintraub, astronomer and author of ‘Is Pluto a Planet?’ Less